Manufacturing Analytics & FDA Compliance

Manufacturing Analytics & FDA Compliance

Pharmaceutical manufacturers must maintain rigorous manufacturing analytics to monitor plant operational processes; many of which can be randomly spot checked by the FDA. CTI designed and implemented an analytics solution that provides instant visibility into manufacturing performance including equipment maintenance, calibration, performance, scheduling, emergency activity, and the current and historical effectiveness of the different plant work teams. A further critical benefit is the generation of the necessary FDA reports, which in the past required a lot of manual work to assemble the data needed.